Preterm InfantsNCT07364500
Protocol-driven Nutrition in Preterm Infants
A study testing Nutrition plan supported by advanced clinical nutrition software in people with Preterm Infants, run by Institute of Health Information and Statistics of the Czech Republic at 5 sites in Czechia.
Trial summary
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic. The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns in the field of… Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Nutrition plan supported by advanced clinical nutrition software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesCzechia
- Study dates
- 21 Aug 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born before 31+6 weeks gestation.
- Signed consent for participation in the project and consent for the processing of personal data.
- Admission to neonatal care in the participating hospital within 24 hours after birth.
Who cannot join
- Congenital malformations.
- Fetal hydrops.
- Intraventricular hemorrhage requiring drainage.
- Necrotizing enterocolitis requiring surgical treatment.
- Surgically treated hydrocephalus.
- Unsigned consent for participation in the project and/or consent for the processing of personal data.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Czechia5 sites, 5 recruiting
- Not yet recruiting
Brno University Hospital
Brno, Czech Republic
Kateřina Fojtíková, MD, fojtikova.katerina@fnbrno.cz
- Recruiting
České Budějovice Hospital
České Budějovice, Czech Republic
Jiří Dušek, MD, dusek.jiri@nemcb.cz
- Recruiting
University Hospital Olomouc
Olomouc, Czech Republic
Martin Wita, MD, martin.wita@fnol.cz
- Recruiting
General University Hospital
Prague, Czech Republic
Blanka Zlatohlavková, MD, blanka.zlatohlavkova@vfn.cz
- Recruiting
Tomáš Baťa Regional Hospital in Zlín
Zlín
Marcela Pekařová, MD, marcela.pekarova@bnzlin.cz
About this study
Official title: Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns in the field of nutrition. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.
Read the detailed description
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
The main goal of the project is standardization of nutrition of premature newborns across healthcare facilities with the aim to optimize postnatal growth and reduce complications associated with prematurity through individualized and closely monitored nutritional plans.
The project will be running in 5 perinatology centers in the Czech Republic. It is expected that 400 premature infants will participate. The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020. The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
- Conditions
- Preterm Infants
- Being tested
- Nutrition plan supported by advanced clinical nutrition software
- Keywords
- preterm infants, nutrition of preterm infants, human milk analysis, nutrition monitoring, Czech Republic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition plan supported by advanced clinical nutrition softwareDietary supplement
Infants undergo regular anthropometric assessments (weight, length, head circumference), and detailed fluid and nutrient intake is recorded. Weekly analysis of the macronutrient composition of maternal or donor milk is conducted, enabling personalized fortification to meet the infant's current needs. The intervention utilizes a dedicated nutrition software tool, incorporating Fenton growth charts, to support clinical decisions and track progress via z-scores compared to term-born infants.
By aligning nutrient supply with individual requirements and promoting early enteral feeding, the project seeks to enhance growth outcomes, minimize risks such as bronchopulmonary dysplasia or retinopathy, and shorten the length of stay in neonatal intensive care.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Other | The nutritional management of enrolled patients will be guided by individualized plans developed by attending physicians, supported by advanced clinical nutrition software enabling precise monitoring and adjustment based on ongoing anthropometric and dietary data. Receives: Dietary Supplement: Nutrition plan supported by advanced clinical nutrition software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-score for body weight at 36 weeks corrected gestational age
Measured: Up to a corrected gestational age of 36 weeks
Z-score for body length at 36 weeks corrected gestational age
Measured: Up to a corrected gestational age of 36 weeks
Z-score for head circumference at 36 weeks corrected gestational age
Measured: Up to a corrected gestational age of 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start21 Aug 2025
- Primary completion30 Nov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- General University Hospital, Prague, University Hospital Olomouc, České Budějovice Hospital, Tomáš Baťa Regional Hospital in Zlín, Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Richard Plavka, prof., Study director, General Hospital University in PragueJiří Dušek, M.D., MHA, Study chair, České Budějovice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364500
- Sponsor's protocol ID
- UZIS 2025/2
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Health Complications in Premature Infants - Protocol-driven Nutrition
- ClinicalTrials.gov ID
- NCT07364500
- Acronym / sponsor ID
- UZIS 2025/2
- Conditions
- Preterm Infants
- Keywords
- preterm infants, nutrition of preterm infants, human milk analysis, nutrition monitoring, Czech Republic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- General University Hospital, Prague, University Hospital Olomouc, České Budějovice Hospital, Tomáš Baťa Regional Hospital in Zlín, Brno University Hospital
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of preterm newborns in the field of nutrition. This will reduce health risks in premature infants and minimize the negative impacts on the overall development of the child and the family of the premature infant.
Detailed description
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
The main goal of the project is standardization of nutrition of premature newborns across healthcare facilities with the aim to optimize postnatal growth and reduce complications associated with prematurity through individualized and closely monitored nutritional plans.
The project will be running in 5 perinatology centers in the Czech Republic. It is expected that 400 premature infants will participate. The project is supported by the European Social Fund (Operational Program Employment Plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020. The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | Other | Dietary Supplement: Nutrition plan supported by advanced clinical nutrition softwareThe nutritional management of enrolled patients will be guided by individualized plans developed by attending physicians, supported by advanced clinical nutrition software enabling precise monitoring and adjustment based on ongoing anthropometric and dietary data. |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born before 31+6 weeks gestation.
- Signed consent for participation in the project and consent for the processing of personal data.
- Admission to neonatal care in the participating hospital within 24 hours after birth.
Key exclusion criteria (6 listed)
- Congenital malformations.
- Fetal hydrops.
- Intraventricular hemorrhage requiring drainage.
- Necrotizing enterocolitis requiring surgical treatment.
- Surgically treated hydrocephalus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition plan supported by advanced clinical nutrition softwareInfants undergo regular anthropometric assessments (weight, length, head circumference), and detailed fluid and nutrient intake is recorded. Weekly analysis of the macronutrient composition of maternal or donor milk is conducted, enabling personalized fortification to meet the infant's current needs. The intervention utilizes a dedicated nutrition software tool, incorporating Fenton growth charts, to support clinical decisions and track progress via z-scores compared to term-born infants. By aligning nutrient supply with individual requirements and promoting early enteral feeding, the project seeks to enhance growth outcomes, minimize risks such as bronchopulmonary dysplasia or retinopathy, and shorten the length of stay in neonatal intensive care. | Dietary supplement | Preterm infants |
Primary outcome
Z-score for body weight at 36 weeks corrected gestational age
Time frame: Up to a corrected gestational age of 36 weeks
Z-score for body length at 36 weeks corrected gestational age
Time frame: Up to a corrected gestational age of 36 weeks
Z-score for head circumference at 36 weeks corrected gestational age
Time frame: Up to a corrected gestational age of 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Plavka, prof. study director
General Hospital University in Prague
Jiří Dušek, M.D., MHA study chair
České Budějovice Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition plan supported by advanced clinical nutrition software in people with Preterm Infants, run by Institute of Health Information and Statistics of the Czech Republic at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Dokoupilová, MSc (+420725441408, daniela.dokoupilova@uzis.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-score for body weight at 36 weeks corrected gestational age (time frame: Up to a corrected gestational age of 36 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.